Immuno-Oncology

Overcoming Challenges in Immuno-Oncology Clinical Research

Immuno-Oncology is moving at an accelerated pace with new approaches to harness the immune system to treat diseases. According to an October 2018 report from The Cancer Research Institute (CRI) titled: “Trends in the global Immuno-Oncology landscape” and published in Nature Reviews Drug Discovery, the number of active agents in immuno-oncology ranging across multiple immunotherapy approaches increased 67% in a single year. Planning I-O clinical trials require expertise and experience in a rapidly changing field.

In this fast-paced field, awareness of the complex challenges and considerations in conducting successful trials for new agents is critical. Sponsors face many complex challenges including operational considerations, biomarkers, safety testing, and imaging needs.

Medpace is a global, full-service CRO with a therapeutic focus in Hematology/Oncology with extensive Immuno-Oncology experience

• Accomplished in-house I-O medical, operational, regulatory, and safety experts
• Knowledgeable in I-O study designs including umbrella studies, basket studies, modality, organ-based, and complex statistical designs such as m-TPI, m-TPI-2, and Bayesian
• Skilled in combination therapy research
• Adept in complex studies with Advanced Therapy Medicinal Products (ATMPs)
• Fully-integrated global central lab with extensive experience working with I-O biomarkers
• Experienced Imaging core lab with skilled in RECIST, irRC, irRECIST, and iRECIST

Central Laboratory Capabilities

I-O biomarkers seek to characterize the relationship between the immune system, the tumor and its microenvironment, and the host. Unique interactions of these factors, as well as I-O biomarker presence and prevalence, contributes to the balance of activation versus suppression of the antitumor immune response. Medpace Central labs has extensive experience working with I-O biomarkers that address the interplay between the immune system and the tumor in four key areas including:

• Tumor antigens
• Inflamed tumor markers
• Immune suppression markers
• Host environment factors

Imaging Core Lab Capabilities

In most oncology clinical trials, tumor response occurs between 8 and 12 weeks. With immuno-oncology agents, however, tumor response may be delayed, and pseudo-progression has been described. This may provide a false assessment of a progressive disease.  Newer radiographic staging systems have been developed for solid tumors and lymphomas. Medpace Imaging Core Labs is experienced in many modalities and measurement criterion for critical imaging end-points in I-O trials including:

• Response evaluation criteria in solid tumors (RECIST), irRC, irRECIST, and iRECIST
• Nuclear medicine imaging including PERCIST and Lugano
• Database optimization for imaging endpoints in I-O trials including EDC and eCRF